EU drugs agency says H1N1 vaccines, Tamiflu safe

LONDON (Reuters) - At least 26 million people across the European Union have been vaccinated against H1N1 and there have been no serious safety problems with the shots, European medicines regulators said on Friday.

The European Medicines Agency (EMEA) also reaffirmed its view that Roche's antiviral drug Tamiflu was safe and effective against the H1N1 virus, which the World Health Organisation (WHO) declared pandemic in June.

EMEA said 26 million people in the European Union received vaccines of Baxter's Celvapan, Novartis's Focetria or GlaxoSmithKline's Pandemrix between May and October while 13 million patients worldwide got Tamiflu.

"The benefit/risk balance of the pandemic vaccines and Tamiflu, used for the current H1N1 influenza pandemic, continues to be positive," the drugs regulator said in a statement.

"The latest data on the safety of the three pandemic vaccines and Tamiflu show no unexpected serious safety issues. The most frequent adverse reactions that have been reported are non-serious and as expected."

EMEA's risk update on Tamiflu is the first since a group of medical experts questioned its efficacy in a review in the British Medical Journal (BMJ) earlier this month, saying there was no evidence it prevented complications like pneumonia in people with influenza.

EMEA did not comment on the review in the BMJ. Last week, the WHO endorsed the report.

Sales of the antiviral drug, also known by the generic name oseltamivir, have soared due to massive government orders since start of the H1N1 swine flu pandemic in April. Roche has contested the review in the BMJ and said it stood by its data, which showed that Tamiflu was effective. The drugs regulator said data submitted for Focetria and Pandemrix confirmed that a single dose was "sufficient in some age groups" to protect against H1N1.

It said it would continue to monitor the all three vaccines and make further recommendations as necessary.